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Orbsen Therapeutics, a NUI Galway biotechnology company focused on the development and commercialization of first-in-class stromal cell immunotherapies, announced the beginning of a phase 2a clinical trial for the treatment of acute respiratory distress syndrome (ARDS) in COVID-19 patients. Between 80-90% of COVID19 deaths are caused by acute respiratory failure.

In hyper-inflammed diseases like COVID19 induced ARDS, stromal cell immunotherapy may work by pushing the overactive immune system into initiating a pro-resolving and anti-inflammatory response.

In pre-clinical studies led and published by Professor John Laffey at NUI Galway ORBCEL demonstrated the ability to mitigate the effects of pneumonia induced ARDS by improving lung oxygenation, reducing inflammation, reducing oedema and decreasing bacterial infection.

This trial of its second-generation immunotherapy, ORBCEL, follows the recent successful completion of a phase 1 trial in 2019 in patients with moderate-severe ARDS. The phase 2a trial, funded by the Wellcome Trust, has been approved by the UK’s Medical Health Regulatory Agency (MHRA) and REALIST has been identified by the UK National Institute for Health Research (NIHR) as a National Urgent Public Health study.

Professors Danny McAuley and Cecilia O’Kane at the UK’s Queen’s University Belfast, are leaders in the development and delivery of new medicines for critical care and ARDS and lead the trial which will includes five clinical sites in the United Kingdom.

A recent statement from the four UK Chief Medical Officers outlined the importance of clinical trials amidst the COVID-19 crisis. Profssor Cecilia O’Kane – who leads the REALIST program highlighted:e “It is only through clinical trials will we be able to determine if new treatments are effective and safe in critically ill patients.”

“The successful completion of ORBCEL’s phase 1 clinical trial confirms our belief in the potential of Orbsen's proprietary stromal cell immunotherapy technologies,” said Dr Larry Couture, CEO of Orbsen Therapeutics. “We believe ORBCEL will prove a valuable addition to the arsenal of therapies to combat the effects of COVID-19.”

Orbsen CSO Dr Steve Elliman noted: “While there are over 100 vaccines & therapies in development targeting the SARS-CoV-2 infection - at present there are no disease modifying therapies approved for ARDS.  We’re delighted the REALIST trial was approved & listed by UK NIHR as an Urgent Public Health Research Study so we can continue assess the potential of our ORBCEL-C therapy in patients with ARDS and contribute to the global response to the COVID19 pandemic.”

In pre-clinical studies led and published by Professor John Laffey at NUI Galway ORBCEL demonstrated the ability to mitigate the effects of pneumonia induced ARDS by improving lung oxygenation, reducing inflammation, reducing oedema and decreasing bacterial infection. Professor Laffey said: “This success is due to a large scale collaborative effort involving Queens University Belfast, Orbsen Therapeutics and the Regenerative Medicine Institute (REMEDI) and CURAM at NUI Galway. It shows that we can rapidly adapt and offer a complex cell therapy intervention to patients in the time and resource pressured setting of a global pandemic. Clinical trials are the only way to rapidly and safely find therapies for this devastating condition.”

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